Indiana Journal of Global Legal Indiana Journal of Global Legal

Studies Studies

Volume 9 Issue 1 Article 12

Fall 2001

Advance Informed Agreement: A Shared Basis for Governing Advance Informed Agreement: A Shared Basis for Governing

Trade in Genetically Modified Organisms? Trade in Genetically Modified Organisms?

Aarti Gupta Columbia University

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Advance Informed Agreement: A Shared Basisfor Governing Trade in Genetically Modified

Organisms?

AARTI GUPTA*

INTRODUCTION

With its completion in January 2000, the Cartagena Protocol on Biosafety

became the first legally binding global regime governing the transnational transferand use of genetically modified organisms.' The existence of this agreement isnoteworthy, given persisting normative and scientific conflicts over potentialharms (ecological, socioeconomic, or to human health) arising from the use ofgenetically modified organisms.2

As its central governance mechanism, the Cartagena Protocol calls for the"advance informed agreement" of an importing country before transnationaltransfers of genetically modified organisms. The notion of "advance informedagreement" has its genesis in the better-known concept of "prior informedconsent," which has been relied upon in the international realm to regulate trade inhazardous waste and restricted and banned chemicals.3 However, in the case ofgenetically modified organisms, the very existence and nature of hazard remains

* Research Scholar, Center for Science, Policy & Outcomes (CSPO), Columbia University. &mail:

aarti-gupta2000@hotmail.com1. See Cartagena Protocol on Biosafety to the Convention on Biological Diversity, Jan. 29, 2000, 39 I.L.M.

1027 (2000) [hereinafter Protocol].2. For a general introduction to the science of genetic engineering, as well as an analysis of risks and benefits

associated with use of GMOs in agriculture, see generally ALAN MCHUGHEN, PANDORA'S PICNIC BASKEr THEPOTENTIAL AND HAZARDS OF GENETICALLY MODIFIED FOODS (2000). For a more critical perspective, seegenerally STEPHEN NOTTINGHAM, EAT YOUR GENES: How GENETICALLY MODIFIED FOOD Is ENTERING OURDIET (1998). For a discussion of ecological concerns relating to use of GMOs, see generally JANE RISSLER &

MARGARET MELLON, PERILS AMONG THE PROMISE: ECOLOGICAL RISKS OFTRANSGENIC CROPS INA GLOBALMARKET PLACE (1993). For a discussion of socioeconomic considerations, see generally Zemede Asfaw &Tewolde B.G. Egziabher, Possible Adverse Socio-economic Impacts of Genetically Modified Organisms, inTRANSBOUNDARY MOVEMENT OF LIVING MODIFIED ORGANISMS RESULTING FROM MODERN BIOTECHNOLOGY:ISSUES AND OPPORTUNITIES FOR POLICY-MAKERS (K.J. Mulongoy ed., 1997).

3. For an analysis of prior informed consent in the governing trade in chemicals, see Robert L. Paarlberg,

Managing Pesticide Use in Developing Countries, in INSTITUTIONS FOR THE EARTH: SOURCES OF EFFECTIVEINTERNATIONAL ENVIRONMENTAL PROTECTION (Peter M. Haas et al. eds., 1993). For an analysis of thehazardous waste regime, see generally Jonathan Krueger, Prior Informed Consent and the Basel Convention: TheHazards of What Isn't Known, 7 J. ENV'T & DEV. 115 (1998).

INDIANA JOURNAL OF GLOBAL LEGAL STUDIES

heavily contested.4 Under such circumstances, institutionalizing "advance

informed agreement" entailed a sustained battle between potential exporters ofgenetically modified organisms, seeking predictability in trade, and potentialimporters, seeking flexibility and discretion in national decision-making. How

have these competing objectives been reconciled within the Protocol'sgovernance mechanism of advance informed agreement?

In addressing this question, I focus on the decision criteria underlyingadvance informed agreement, i.e., the criteria upon which importer decisions

about accepting or restricting genetically modified organisms are to be based.Three such decision criteria were debated during the Cartagena Protocolnegotiations. These were sound science; the precautionary principle; andsocioeconomic considerations. Their definitions, as well as their relationship to

one another, remain heavily contested and transcend the is sue of biosafety, sincethey have been disputed in other influential global fora such as the World TradeOrganization (WTO), as well. 5 I examine below the nature of conflicts over

decision criteria for advance informed agreement during negotiation of theCartagena Protocol, the final compromise, and the implications for biosafetygovernance.

I. IMPLEMENTING ADVANCE INFORMED AGREEMENT:

DISPUTES OVER DECISION CRITERIA

During negotiation of the Cartagena Protocol, potential exporters ofgenetically modified organisms were organized into the Miami Group, consisting

of countries at the forefront of producing "living modified organisms" (LMOs).6

This group includes the major LMO-producing and agriculture exporting

4. See AARTI GuPTA, FRAMING "BIOSAFETY" IN AN INTERNATIONAL CONTEXT 5 (Belfer Ctr. for Sci. & Int'lAffairs, ENRP Discussion Paper E-99-10, 1999) (The term "advance informed agreement" results from preciselysuch conflict. It was insisted upon by the United States during negotiation of the Convention on BiologicalDiversity (CBD) in 1992 to avoid use of the term "prior informed consent" (given its association with hazardoussubstances) for GMOs.), at http://environment.harvard.edu/gea/pubs/e%2D99%2D10.pdf

5. The most prominent recent airing of disputes over these decision criteria within the WTO is evident in thetransatlantic dispute between the United States and the European Union over trade in hormone treated beef. Sew;e.g., WTO, Appellate Body, EC Measures Concerning Meat and Meat Products (Hormones), WT/DS26/AB/R

(Jan. 16, 1998), at http://www.wto.org/english/tratop_e/dispu e/hormab.pdf [hereinafter EC Measures].

6. GMOs are called "living modified organisms" in the Protocol. This change was insisted on by the UnitedStates to deflect attention from "genetic" modification as the focus of regulatory attention. I use the term "LMO"in the remainder of this essay to ensure consistency with Protocol usage. For a more detailed analysis of thislanguage change, see generally Aarti Gupta, Creating a Global Biosafety Regime, 2 INT'L J. BIoTEcn 2)5 (2000

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countries of Argentina, Australia, Canada, Chile, the United States, and Uruguay. 7

A coalition of pharmaceutical, food, and agricultural companies, the GlobalIndustry Coalition, supported the Miami Group in its push for predictability inLMO trade.8 Other key actors in the Cartagena Protocol negotiations include theEuropean Union, the "Like-Minded Group" of developing countries, andenvironmental and consumer safety groups. 9 Table 1 below summarizes the maindivides over decision criteria during negotiation of the Protocol.

Table 1: Disputes over criteria for importer decision-making

Miami Group European Union Like-Minded GroupNational decisions about National decisions about National decisions aboutLMO transfers should be LMO transfers should be LMO transfers should bebased upon a sound based upon a scientific based upon scientific riskscientific risk assessment risk assessment and the assessment; theand should be precautionary principle; precautionary principle;

compatible with the WTO no deference to the WTO and on socioeconomicfactors; no deference tothe WTO

As summarized in the table, a key divide between the Miami Group and theEuropean Union has been over whether a scientifically sound risk assessment, ascalled for by the Miami Group and the Global Industry Coalition, should be the

7. See CLIVE JAMES, INT'L SERV. FOR THE ACQUISITION OF AGRI-BIOTECH. APPLICATIONS [ISAAA], BRIEFNo. 8, GLOBAL REVIEW OF COMMERCIALIZED TRANSGENIC CROPS: 1998 iii-iv (1998) (In 1998, 27.8 millionhectares were planted with genetically modifed crops worldwide. Of this area, the United States contributed 74%,Argentina 15%, Canada 10% and Australia 1%. Mexico, Spain, France, China, and South Africa constituted theremaining, each with less than 1%. The main crops grown in 1998 were soybean (consisting of 52% of the globalarea), corn (constituting 30%), as well as cotton, canola and potato. The main genetic modifications were forherbicide tolerance (71% of all genetic modification) and insect resistance (2 1%). The growth in area devoted togenetically modified crops from 1997 to 1998 (from I I to 27.8 million hectares) was concentrated in industrializedcountries. Global sales from transgenic crops were estimated at $75 million in 1995, $235 million in 1996, $670million in 1997, and from $1.2-$1.5 billion in 1998.), http://www.isaaa.org/publications/briefs/Brief_8.htm.

8. Press Release, Global Indus. Coalition, Biodiversity Jeopardized in Cartagena Biosafety Negotiations (Feb.16, 1999) (on file with author) (The Global Industry Coalition was established in 1998 and represents "over 2200firms from more than 130 countries worldwide [and] includes companies from a variety of industrial sectors,including plant and animal agriculture, food production, human and animal health care, forestry and theenvironment.").

9. See Aarti Gupta, Searching for Shared Norms: Anticipatory Global Governance of Biosafety (2001)(unpublished Ph.D. dissertation, Yale University) (on file with author) for a detailed analysis and history of thegenesis of these negotiating alliances. See also Aarti Gupta, Governing Trade in Genetically Modified Organisms:The Cartagena Protocol on Biosafety, 42 ENV'T 23, 26 (2000) for additional analysis of the factors shaping the

biosafety perspectives of these groups.

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sole appropriate decision criterion, or whether the precautionary principle is also a

legitimate basis upon which to make decisions about LMO transfer and use. This

conflict is fueled partly by the increasing public opposition to genetically modified

organisms in Europe. 10 The central justification offered by the Miami Group and

the Global Industry Coalition for relying on sound science was that it provided the

only objective and standardized basis for a global biosafety governance regime. 1

As stated emphatically by the Global Industry Coalition: "decisions under the

Protocol... must be based on sound and objective science. To do otherwise,

will severely undercut the effectiveness and integrity of the Protocol.... 2

A corollary to the call for sound science was that the precautionary principle

was an ill-defined, nebulous concept that was open to abuse and could serve as a

front to further protectionist or competition-driven trade agendas. Its status as a

principle was also questioned by the Miami Group, who viewed it as a poorly

defined approach to decision-making.1 3 As one U.S. delegate noted, the

precautionary approach, as articulated in the 1992 Rio Declaration, 14 was "so

wide-open that you can drive a truck through it."' 5 Thus, as the Miami Group

and industry argued, using the precautionary approach as a criterion for importer

choice prior to trade in LMOs would make predictable global rules governing

such trade unattainable.

10. For an analysis of changing perceptions of LMOs in countries of the European Union, see George Gaskell et

al., Biotechnology and the European Public 18 NAT. BIOTECH. 935 (Sept. 2000).

11. For the perspective of a key Miami Group member, Australia, on the Protocol, see generally Austi. Dep't of

Foreign Affairs & Trade, at http://www.dfat.gov.au/environment/bsp.

12. Posting of Dr. Helma Hermans, Executive Secretary Green Industry Biotechnology Platform,

sciwrico@wirehub.nl, to Observers to the CBD Meeting (Feb. 10, 1999, 12:51 p.m.) (on file with author)

[hereinafter Posting from Dr. Helma Hermans]; see also Global Indus. Coalition, Basic Requirements for a

Successful Biosafety Protocol (Feb. 1999) (position paper on file with author) [hereinafter Basic Requirements];Press Release, Cartagena, Columbia, Global Indus. Coalition, Biodiversity Jeopardized in Cartagena Protocol

Negotiations (Feb. 19, 1999) (on file with author).

13. For an interpretation of precautionary decisions as constituting an approach to decisionmaking rather than a

principle, and arguments made by the United States in the beef-hormone conflict, see EC Measures, supra nce 5.

For more detailed analysis of the beef hormone case, and, more generally, for options to reconcile the trade regime's

obligations with multilateral environmental agreements such as the Protocol, see also Frank Biermann, 7heRis*

Tide of Green Unilateralism in World Trade Law: Options for Reconciling the North-South Conflict, 35 J.

WORLD TRADE 421, 421-23 (2001).

14. Rio Declaration on Environment and Development, adopted by the U.N. Conference on Environment and

Development, June 13, 1992, princ. 15, 31 I.L.M 874, 879 (1992) [hereinafter Rio Declaration] ("In order to

protect the environment, the precautionary approach shall be widely applied by States according to their

capabilities. Where there are threats of serious or irreversible damages, lack of full scientific certainty shall not be

used as a reason for postponing cost-effective measures to prevent environmental degradation.").

15. Interview with Miami Group Delegate, in Washington, D.C. (Mar. 1999) [hereinafter Interview with Miami

Group Delegate].

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On the other hand, those advocating a precautionary approach, including theEuropean Union and green groups, protested its characterization as antithetical toscience. 16 Green groups, in particular, argued that sound science in contestedareas such as biosafety was a science that was explicitly precautionary in the faceof scientific uncertainties. 7

While developing countries supported the European Union in its push toinclude the precautionary principle as a legitimate decision criterion, this conflictwas primarily between the European Union and the Miami Group. For mostdeveloping countries, the key concern was inclusion of non-scientificsocioeconomic considerations in the Protocol's decision criteria for advanceinformed agreement. The socioeconomic concerns voiced by developingcountries, and supported by green groups, included new forms of dependencieson technologically advanced countries or multinational companies as a result ofgrowing private ownership of transgenic seed. Concerns also included thepossible effect on traditional livelihoods of growing reliance on LMOs inagriculture. In demanding that socioeconomic factors be included, developing

countries and green groups argued that concerns over LMO transferstranscended narrowly-defined conceptions of harm that were assessable andquantifiable through technical risk assessments (even those that could account forscientific uncertainties).'

8

Most OECD countries and industry noted the extreme importance ofsocioeconomic factors in national decision-making about adoption of newtechnologies, yet insisted that such concerns were more suitably addressed

16. For a recent clarification of the European Union's view on the precautionary principle and its

implementation, see Communication from the Commission on the Precautionary Principle, COMM'NOFTHEBEJRCOMMUNITIES (Feb. 2, 2000), available at http://europa.eu.int/comm/dgs/healthconsumer/library/

pub/pub07_en.pdf.17. For a detailed discussion of the relationship between "sound" science and precaution, see generally Nancy

Myers, The US. and the Precautionary Principle: An NGO Response in the Context of the Cartagena Protocol

(Dec. 2000), available at http://www.sehn.org/rtfdocs/lCCP.rtf See also The Science and Environmental Health

Network (SEHN), http://www.sehn.org (giving a similar analysis).18. See THIRD WORLD NETWORK, OPEN LETTERTO DELEGATES TO THE RESUMED SESSION OF THE FIRST

EXTRAORDINARY MEETING OF THE CONFERENCE OF THE PARTIES TO THE CONVENTION ON BIOLOGICAL

DIVERSITY, ESSENTIAL ELEMENTS OF A BIOSAFETY PROTOCOL 7 (Jan. 24, 2000) (explaining that most green

groups involved in Protocol discussions have emphasized the need for inclusion of socioeconomic impacts in the

Protocol's decision criteria and stating that "socioeconomic considerations are an integral part of assessing the

impact of GMOs... [which] could ... impair or displace indigenous technologies . . . displace crops or exports

and undermine a country's economy and cause social instability.. .") (text on file with author); see also WORLD

WIDE FUND FOR NATURE, POSITION STATEMENT, FIFTH MEETING OF THE OPEN-ENDED AD HOC WORKING

GROUP ON BIOSAFETY (Aug. 1998) (on file with author).

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through domestic regulations, rather than through a global governance regime. 19In arguing against inclusion of socioeconomic factors as a criterion governingimporter choice, a key concern for many OECD countries and industry was thatsuch inclusion would conflict with multilateral trade obligations. As the GlobalIndustry Coalition put it: "introduction of socio-economic considerations woulderect unacceptable and inappropriate barriers to international trade, in conflictwith countries' WTO obligations." 20

These groups argued, instead, for the Protocol's decision criteria to becompatible with the WTO's science-based obligations governing trade insubstances of contested risk. These obligations are contained in the traderegime's Agreement on the Application of Sanitary and Phytosanitary Measures(SPS Agreement), which mandates that all national sanitary and phytosanitarystandards relating to plant, animal, and human health and safety have a scientificjustification to prevent their becoming unacceptable non-tariff barriers to trade.21

The SPS Agreement does allow for provisional restrictions on trade in the eventof insufficient scientific evidence of harm. In its understanding of precautionarydecisions, article 5.7 of the SPS Agreement allows that:

In cases where relevant scientific evidence is insufficient, aMember may provisionally adopt sanitary and phytosanitarymeasures on the basis of available pertinent information.... Insuch circumstances, Members shall seek to obtain the additionalinformation necessary for a more objective assessment of risk,and review the sanitary or phytosanitary measure accordinglywithin a reasonable period of time.22

Such precautionary measures are, however, to be maintained only on aprovisional basis as more scientific data on risk is sought. Thus, the main thrust

19. Interview with Miami Group Delegate, supra note 15.20. Posting from Dr. Helma Hermans, supra note 12; see also Basic Requirements, supra note 12. Forsirnix

industry perspectives, see generally Biotech. Indus. Org., The Biosafety Protocol: An Overview, athttp://www.bio.org/food&ag/bspoverview.html (last visited Jan. 14, 2002).

21. Agreement on the Application of Sanitary and Phytosanitary Measures, Apr. 15, 1994, MarrakeshAgreement Establishing the World Trade Organization [hereinafter WTO Agreement], Annex IA, 69 (1994)[hereinafter SPS Agreement], available at http://www.wto.org/english/docs-e/legal-e/I 5-sps.pdf According to theSPS Agreement, "[m]embers shall ensure that any sanitary or phytosanitary measure is applied only to the extentnecessary to protect human, animal or plant life or health, is based on scientific principles and is not maintainedwithout sufficient scientific evidence ..... Id. art. 2.2.

22. Id. art. 5.7.

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of the SPS Agreement's science-based obligations is to ensure that national healthand safety decisions are justifiable based on a scientific risk assessment.

The scientific validity of national health and safety measures is to bedemonstrated through a formal risk assessment. The SPS Agreement addressessocioeconomic considerations only in including a limited set of "relevanteconomic factors" within the required risk assessment. These include "thepotential damage in terms of loss of production or sales in the event of the entry,establishment or spread of a pest or disease; the costs of control or eradication inthe territory of the importing Member; and the relative cost-effectiveness ofalternative approaches to limiting risk. 2 3

These are socioeconomic considerations relating to potential economicdamage resulting from sanitary or phytosanitary harm. Broader considerationsthat are distinct from ecological or human health harm, such as the social needfor a traded product that may pose risk, its public acceptability, or consumeropposition to it based on cultural or ethical grounds, are excluded from the SPSAgreement's science-based decision criteria.24 As seen most prominently in thebeef-hormone conflict, and as discussed later, implementation of such decisioncriteria has remained contested.

Similar disputes over decision criteria for advance informed agreement duringnegotiation of the Cartagena Protocol reveal clearly that the utility of having aglobal biosafety regime varied greatly for the different groups. While theEuropean Union, developing countries, and green groups saw the global biosafetyregime as a vehicle through which to institutionalize flexibility in decision-makingabout trade in genetically modified organisms (a flexibility deriving from nationaldecisions based on the precautionary principle and/or socioeconomicconsiderations), the Miami Group and industry saw the regime as a vehiclethrough which to institutionalize predictability in decision-making about trade (apredictability deriving from decisions based on sound science). This ongoingconflict over the raison d'9tre of a global biosafety regime was reflected inconflicts over the decision criteria underpinning advance informed agreement.

23. Id. art. 5.3.24. See Wolfgang van den Daele, Interpreting the Precautionary Principle: Political Versus Legal

Perspectives, in I FORESIGHT AND PRECAUTION 213,220 (M.P. Cottam et a]. eds, 2000) (noting the debate in theEuropean Parliament in 1992 over a European Green Party proposal that new technologies pass tests not only ofsafety, efficacy, and quality but also a "fourth hurdle" of social need).

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II. THE OUTCOME: PRIVILEGING SCIENCE-BASED

ADVANCE INFORMED AGREEMENT

The Cartagena Protocol's final compromise on decision criteria prior to LMOtrade calls for importer decisions to be based upon a "scientifically sound" riskassessment; precautionary action in the face of scientific uncertainty aboutadverse impacts; and a very circumscribed inclusion of socioeconomic

considerations. 25 As I argue below, such criteria can be interpreted as privilegingscience-based decisions about LMO transfers. In the remainder of this essay, Ielaborate on how the decision criteria in the finalized Protocol privilege scienceand conclude with some implications for global biosafety governance.

In its call for sound science, the Cartagena Protocol mandates that LMOimporter decisions be based upon a quantitative risk assessment. It furthermandates that such risk assessments be "carried out in a scientifically soundmanner... taking account of recognized risk assessment techniques. '26 TheProtocol's understanding of what constitutes a scientifically sound riskassessment is contained in its Annex II. Importantly, it is conceded here that thecriteria to be taken into account and the data to be generated in a quantitative riskassessment cannot be internationally mandated, given the diverse agroecological(and, as some would argue, socioeconomic) environments within which riskassessments are to be undertaken. Thus, the Protocol explicitly states that "therequired information [in a risk assessment] may vary in nature and level of detailfrom case to case, depending on the living modified organism concerned, itsintended use and the likely potential receiving environment. '27 In recognition ofthis, the information to be evaluated in a risk assessment is listed in the Annex as"points to consider" rather than as mandatory criteria to be assessed in all cases.

This deference to context-based differences in risk assessmentnotwithstanding, there is still the stipulation that a risk assessment must bescientifically sound. Yet, in this normatively contested area, there is littleagreement on what constitutes "sound" science. A striking illustration of this isprovided by disputes over a key risk assessment principle-substantialequivalence--that currently underpins safety evaluations of genetically modified

25. Protocol, supra note 1, arts. 10.1, 10.6, 11.6, 15, 26, at 1031, 1032, 1033-34, 1039.26. Id. art. 15, at 1033 (emphasis added).27. Id. annex III, para. 6, at 1045.

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organisms. 28 This term was coined by the Organization for EconomicCooperation and Development (OECD) in 1993 in an attempt to develop shared"concepts and principles" to underlie safety evaluations of genetically modifiedorganisms. 29 The main premise of substantial equivalence is that the safety of atransgenic food should be assessed relative to existing comparable conventionalfoods, i.e. that the "substantial equivalence of a transgenic food is established by ademonstration that the characteristics assessed for the genetically modifiedorganism .. .are equivalent to the same characteristics of. .. conventional

foods."30

This concept has fueled much debate since its elaboration in the early 1990s,even as it has been adopted by many OECD countries in regulation of geneticallymodified organisms.31 Substantial equivalence has also been endorsed as anadequate scientific basis for safety evaluations of genetically modified organismsby international organizations such as the United Nations Food and AgriculturalOrganization (FAO) and the World Health Organization (WHO). 32 A series ofexpert consultations organized by these two organizations has recommended thatsafety evaluations of transgenic foods be based on the concept of substantialequivalence.)

Significantly, however, the latest FAO/WHO Expert Consultationacknowledges that:

Several countries have used the concept of substantialequivalence as an important component of the safety evaluationsof food and food ingredients derived from genetically modifiedplants. They have found this approach to be scientifically soundand practical. Nevertheless, there has not been a universal

28. FOOD & AGRIC. ORG. OF THE UNITED NATIONS, BIOTECH. AND FOOD SAFETY: REP. OF A JOINT

FAO/WHO CONSULTATION (1996), http://www.fao.org/waicent/faoinfo/economic/esn/biotech/tabconts.htm[hereinafter FAO 1996]; FOOD & AGRIC. ORG. OF THE UNITED NATIONS, SAFETY ASPECTS OF GENETICALLY

MODIFIED FOODS OF PLANT ORIGIN: REP. OF A JOINT FAO/WHO CONSULTATION OF FOODS DERIVED FROM

BIOTECH. (2000), http://www.who.int/fsf/GMfoodIFAO-WHOConsultationreport_2000.pdf [hereinafter FAO2000]; Eric Millstone et al., Beyond "Substantial Equivalence, 401 NAT., Oct. 7, 1999, at 525-26.

29. OECD, SAFETY EVALUATION OF FOODS DERIVED BY MODERN BIOTECHNOLOGY: CONCEPTS AND

PRINCIPLES (1993), available at http://www.oecd.org/pdf/M00007000/M00007573.pdf [hereinafter OECD].

30. FAO 1996, supra note 28, at 22.

31. FAO 2000, supra note 28.32. For the initial elaboration of this concept and early debates about it, see OECD, supra note 29, and FAO

1996, supra note 28. The latest FAO/WHO expert consultation on safety evaluations of transgenic foods contains a

detailed account of recent debates on this issue. See FAO 2000, supra note 28.33. FAO 1996, supra note 28.

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consensus on the application of this concept. This has resulted

in criticism that the approach does not provide a sufficient basisfor safety and calls for national governments and internationalbodies to consider alternative approaches. 34

However, the report concludes that: "[T]here [are] presently no alternativestrategies that would provide a better assurance of safety for genetically modifiedfoods than the appropriate use of the concept of substantial equivalence... [t]heapplication of the concept of substantial equivalence contributes to a robust safetyassessment framework., 35 Yet, continuing conflicts and critiques of thisscientific tenet abound.3 6 For example, a controversial and widely discussedarticle in the influential journal Nature, entitled "Beyond SubstantialEquivalence,, 37 critiques continued reliance on substantial equivalence in safetyassessments of genetically modified crops and foods. The authors question boththe adequacy of the tests relied upon to establish equivalence and the underlyingassumption that equivalence of transgenic with conventional foods can beestablished. Their conclusion, under the provocative title "an anti-scientific test,"states that:

Substantial equivalence is a pseudo-scientific concept because itis a commercial and political judgment masquerading as if itwere scientific. It is, moreover, inherently unscientific becauseit was created primarily to provide an excuse for not requiringbiochemical or toxicological tests. It therefore serves todiscourage and inhibit informative scientific research.38

Notwithstanding such persisting conflicts over scientific principles to regulatebiotechnology, the Cartagena Protocol calls for a "scientifically sound" riskassessment as the central basis for LMO import decisions. Clearly, then, a callfor "sound" science will not provide the predictability in trade desired by theMiami Group or industry. Moreover, the Protocol's call for a scientifically soundrisk assessment is strikingly similar to the SPS Agreement's science-based

34. FAO 2000, supra note 28, at I (emphasis added).

35. Id. at 20.36. For an analysis of the disputed concept of substantial equivalence, see Millstone et al., supra note 28.37. Millstone et al., supra note 28.38. Id. at 526 (emphasis added).

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obligations. Its interpretation in the new forum of the Cartagena Protocol istherefore likely to remain as contested as it has been in the SPS Agreement.

As is increasingly clear, science alone cannot resolve fundamental valueconflicts, notwithstanding continued calls to base decisions in normatively

contested areas on science. In areas where the science itself is contested, a callfor "sound" science is disingenuous, since it cannot resolve, on "objective"

scientific grounds alone, the critical question of "whose" sound science. 39 The

concept of sound science has been exhaustively analyzed and critiqued in recentyears, not least because it is privileged as a basis for decision-making in the

multilateral trade regime.4 °

A critically important component of this debate, which I explore next, is therelationship between sound science and the precautionary principle. The

precautionary principle is becoming an increasingly important component ofgovernance regimes dealing with environmental and human health and safety.Thus, a shared understanding of the precautionary principle would go a long way

toward the development of transnationally legitimate governance precepts incontested areas such as biosafety.4 ' Yet, as argued below, the CartagenaProtocol's language on precaution does not as yet yield such a shared

understanding.

The Protocol's provisions on precautionary decision-making state that:

Lack of scientific certainty due to insufficient relevant scientificinformation and knowledge regarding the extent of the potentialadverse effects of a living modified organism on the

39. For an analysis of how perceptions of the legitimacy (i.e., fairness) and the salience (i.e., relevance) of

scientific input are as critical in determining whether science can influence policymaking as any shared perceptionsof its "soundness" alone (i.e., its technical credibility), see generally INFORMATION AS INFLUENCE: HOwINSTITUTIONS MEDIATE THE IMPACT OF SCIENCE ASSESSMENTS ON GLOBAL ENVIRONMENTAL AFFAIRs(Willa C.Clark et al. eds., forthcoming 2002). See also Frank Biermann, Big Science, Small Impacts-in the South? TheInfluence of Global Environmental Assessments on Expert Communities in India, I I GLOBAL ENVTL. CHANGE297 (2001) for analysis of how global science may have minimal influence in India, if developing country concernsare not reflected or if developing country scientists do not participate in such global assessments.

40. See generally David Wirth, The Role of Science in the Uruguay Round and NAFTA Trade Disciplines, 27

CORNELL INT'L L.J. 817 (1994) (analyzing the science-based provisions of the SPS Agreement); Les Levidow &Susan Can, Unsound Science: Transatlantic Regulatory Disputes over GM Crops, 2 INT'L J. BIOTECH. 257(2000) (critiquing the concept of sound science as it relates to GMOs); AARTI GUPTA, Sound Science in GlobalGovernance of Biosafety, in LOCALIZING AND GLOBALIZING: KNOWLEDGE CULTURES OF ENVIRONMENT ANDDEVELOPMENT (Sheila Jasanoff & Marbeth Long-Martello eds., forthcoming 2002) (analyzing the call for "saund

science" in the Protocol negotiations).41. For an overview of debates on the precautionary principle, see generally INTERPRETING THE

PRECAUTIONARY PRINCIPLE (Tim O'Riordan & James Cameron eds., 1994).

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conservation and sustainable use of biological diversity in theParty of import, taking also into account risks to human health,shall not prevent the Party from taking a decision, asappropriate, with regard to the import of the living modifiedorganism . . . in order to avoid or minimize such potential

adverse effects.42

This language has been hailed by the European Union, developing countries,and green groups as the first inclusion of the precautionary principle in theoperational part of a global environmental agreement and one of the mostnoteworthy contributions of the Cartagena Protocol.4 3 In contrast, however, theMiami Group and industry representatives have emphasized that the Protocol'slanguage on precaution does not go further than the discretion already permittedto importers of risky products under the multilateral trade regime and its SPSAgreement.44

It is useful, therefore, to examine more closely the language in the Protocol toassess whether a shared basis for governance, generalizable to other anticipatoryissues, is discernible here. Examining the Protocol's language on precautionreveals, first and foremost, that it does not operationalize the precautionaryprinciple, as widely alleged, since no single universally shared version exists.Instead, the Protocol's language reflects a mix of existing understandings ofprecaution as articulated in other global fora, including Principle 15 of the RioDeclaration and article 5.7 of the SPS Agreement.

Comparing these various versions reveals that the Protocol's language onprecaution is largely compatible with both Principle 15 of the Rio Declaration andarticle 5.7 of the SPS Agreement. Although these articulations are compatible,Principle 15 can be construed as setting a stricter standard for precautionary

42. Protocol, supra note 1, art. 10.6, 11.8, at 1031, 1032.

43. See, e.g., Montreal 2000: An Amazing Compromise, 59 COURRIER DE LA PLANETE 7 (2001) (intaviewingChristoph Bail, a lead spokesperson for the European Union during the Protocol negotiations); see also THIRD

WORLD NETWORK, supra note 18.44. Interview with Miami Group Delegates, in Montreal (Jan. 2000). For written statements on the key

provisions of the Protocol, issued two weeks after finalization of the Protocol at the end of January 2000, see OFFIE

OF THE SPOKESMAN, U.S. DEP'T STATE, FACT SHEET: THE CARTAGENA PROTOCOL ON BIOSAFETY (Feb. 16,

2000), available at http://usinfo.state.gov/topical/global/biotech/00021601.htm. The Fact Sheet states that "the

language [on precaution] does not replace science-based decision-making nor does it authorize decisions contrary to

a country's WTO obligations." Id at (e). For a similar interpretation from another key Miami Group member,Australia, see also DEP' T OF FOREIGN AFFAIRS & TRADE, ENV' T AUSTL., DISCUSSION PAPER: PREPARATIONSOF

THE FIRST MEETING OF THE INTERGOVERNMENTAL COMMITTEE ON THE CARTAGENA PROTOCOL ON BIOSAFETY

(Oct. 2000), at http://www.dfat.gov.au/environment/bsp/biosub/discussionpaper.htm#outline.

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actions than the Protocol, given its injunction that precautionary actions are to betaken (only) when "serious and irreversible" damage might result from inactionand when such actions meet an additional criterion of cost-effectiveness. 45 Atthe same time, Principle 15 also includes the concept of "full" scientific certainty,which is often equated with a "zero-risk" approach by opponents of thislanguage, who argue that full scientific certainty about lack of harm is neverobtainable.

A comparison with Principle 15 of the Rio Declaration is particularly relevantto evaluating whether the Cartagena Protocol's inclusion of precaution canprovide a shared basis for action. This is because there is a separate and explicitreference to Principle 15 in the Protocol's overall objectives: "In accordance withthe precautionary approach contained in Principle 15 of the Rio Declaration onEnvironment and Development, the objective of this Protocol is to contribute toensuring an adequate level of protection in the field of the safe transfer, handlingand use of living modified organisms...46

Including two compatible, yet slightly distinct, versions of precaution withinthis one global regime allows for multiple and potentially conflicting interpretationsabout the legitimate triggers for precautionary action under the Protocol.Therefore, while it certainly provides flexibility in interpretation to importers ofLMOs who wish to exercise precaution in allowing LMO transfers, it does not yetprovide a common basis for action in this contested area. Although inclusion ofthis language in the Protocol is indeed a significant first step, its articulation heredoes not categorically shift the advantage to either the proponents or theopponents of reliance on precaution in governing transfers of LMOs. Rather, itensures that the battle of interpretation will continue in this and other fora on acase-by-case basis.47

Notwithstanding the potential for multiple interpretations, however, theProtocol's language on precaution contains one important and relativelyunambiguous similarity to the multilateral trade regime's understanding ofprecaution. As seen earlier from the language of the SPS Agreement's artic le 5.7,

45. See Rio Declaration, supra note 14, princ. 15, at 879.46. Protocol, supra note I, art. 1, at 1027 (emphasis added).47. One difference between article 5.7 of WTO-SPS and the Protocol is that the SPS Agreement's language

emphasizes that precautionary decisions are to be provisional and should be reviewed within a "reasonable period"of time. SPS Agreement, supra note 21, art. 5.7. The Protocol's version identifies no time frame within whichprecautionary decisions are to be reviewed and can thus be construed as allowing more flexibility to countries intaking import-restrictive actions in the face of scientific uncertainty. However, the SPS Agreement's injunction toreview actions within a reasonable period of time is sufficiently vague so as to make this distinction less critical.

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the starting point of legitimate precautionary action in the trade regime is a

science-based risk assessment. The Protocol's language can be read as a similar

call for precautionary actions to be grounded in a quantitative risk assessment.This i evident from the emphasis in the Protocol's language on scientific

uncertainty about the extent of an adverse impact posed by an LMO, rather thanuncertainty about whether or not an adverse impact exists. This emphasis on the

extent of an adverse impact can be interpreted as requiring prior scientific

evidence of the existence of an adverse impact before precautionary action can

legitimately be taken.

Thus, the language on precaution in the Cartagena Protocol can also be

interpreted as not allowing countries to go beyond what is already permittedwithin the SPS Agreement's science-based obligations. It can be interpreted as

privileging a quantitative risk assessment as the legitimate starting point forprecautionary action, as does the SPS Agreement. Hence, the language on

precaution can be read as privileging science-based importer decision-making

prior to LMO transfers, in a manner similar to the call for a "scientifically sound"

risk assessment.This privileging of science is further reinforced by the manner in which

socioeconomic considerations are addressed by the Cartagena Protocol. In its

final compromise on this issue, the Protocol allows for very limited consideration

of adverse socioeconomic impacts in importer decisions about LMO transfers.

Specifically, it allows countries to "take into account, consistent with their

international obligations, socioeconomic considerations arising from the impact of

[living modified organisms] on the conservation and sustainable use of biological

diversity.... 8

This is a very narrow formulation in that it links socioeconomic impacts to

impacts on biodiversity, in a manner similar to the WTO's treatment ofsocioeconomic factors in the SPS Agreement. This excludes many concerns of

particular interest to developing countries, such as loss of traditional livelihoods or

increased dependence on privately controlled seed. In addition, the proviso that

decisions based on socioeconomic considerations are to be consistent with a

country's international obligations eisures that the Protocol's allowance of

socioeconomic factors does not go beyond what the WTO already permits. Asthe lead negotiator for developing countries, Tewolde Berhan Egziabher of

48. Protocol, supra note 1, art, 26,. at 1039.

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Ethiopia, put it following a temporary collapse in negotiations for the Protocol inFebruary 1999 in Cartagena:

The Miami Group and European Groups would not allow theuse of socioeconomic variables even in risk assessment. The[draft article on socioeconomic considerations] is uselessbecause it is qualified by the phrase 'tonsistent with theirinternational obligations" which means, in effect, that they haveto give priority tofacilitatingfree trade. Thus Southern nationsare expected to accept whatever disruption genetically modifiedorganisms might cause their societies and economies.4 9

The limited inclusion of socioeconomic factors in the Protocol furthervalidates the claim in this essay-that science-based choice is privileged in thisglobal regime. Such a privileging of science-based choice can be seen as akin toa problematic technicalization of what are fundamentally normative conflicts inthe area of biosafety. One potentially far-reaching implication of such aprivileging of science in global governance fora is that a broad range of concernsabout the nature and consequences of technological change may have to bearticulated by all groups in the language of technical risk. Although normativeconcepts such as justice, equity, fairness, or choice will remain key drivers inconflicts over global governance, they may increasingly need to be recast in thelanguage of technical harm.

A striking example is provided by the rationales relied upon to regulateimports of transgenic agricultural commodities in India. In the global forum,developing countries, including India, justified the need for national choice prior totrade in LMOs by invoking concerns over risks to biodiversity or human health.However, the primary concern in India over imports of transgenic commodities

are socioeconomic, rather than related merely to ecological or health harmnarrowly defined. Yet, such broader national-level concerns over technologicalchange were couched in the global arena in terms of risk in order to receive ahearing within global governance fora that privilege the language of technically

49. Tewolde Berhan G. Egziabher, Safety Denied, OUR PLANET, June 1999, athttp://www.ourplanet.com/imgversn/102/viewpoint.html (emphasis added).

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assessable harm.50 Such a privileging of technical risk assessment as a basis fornational decisions is likely to have particularly important but as yet under-examined implications for developing countries, which rely relatively less ontechnical input into decision-making, and which have to consider diversesocioeconomic priorities in governing uptake and safe use of new technologies.

In anticipatory areas of technological change, then, where the scienceremains contested and uncertain, and where concerns about adoption and safeuse of technologies transcend scientifically measurable harm, it remains importantto go beyond science-based mediation of normative conflicts. In addition toscientific input, some form of social impact assessment should also be a criticalcomponent of anticipatory global and national governance regarding the safeuptake and use of new technologies. 5! While any call to assess the social impactof technological change appears to go against the grain of the fundamentalpremises of an increasingly globalized market system, its perils and its promisefor anticipatory governance need to be explored.52

The ardent debates over the precautionary principle as a basis for decision-making in the Cartagena Protocol provide a precursor to the greater set ofchallenges inherent in agreeing to and implementing any form of social impactassessment as a basis for transnational governance. However, the multiplechallenges inherent in this endeavor should not be reason enough to abstain fromconsidering such governance innovations in the search for shared bases foraction.

III. WHY GLOBAL GOVERNANCE STILL MATTERS

In the final analysis, even though the biosafety area remains heavilycontested, the rationale for anticipatory global governance regimes is clear: thereis dire need for institutional and governance structures to co-evolve withtechnological changes that have transformative potential, rather than to follow in

50. For a detailed analysis of the relevance of the Protocol for biosafety regulation in India, see Aarti Gupta,Belfer Ctr. for Sci. & Int'l Affairs, Governing Biosafety in India: The Relevance of the Cartagena Protocol (Oct2000), at http://environment.harvard.edu/gea/pubs/2000%2D24.pdf.

51. Some green groups have also called for such assessments. See, e.g., WORLD WIDE FUND FOR NATURE,supra note 18; see also Gaskell et al., supra note 10, at 938 (stating that "international debate and decision-making must go beyond evidence based solely on scientific risks. The moral and ethical dimensions ofbiotechnology that underlie public concerns need to be understood and taken into account.").

52. For detailed discussion of the innovative concept of "real-time technology assessment" to observe andinfluence the process by which social values become embedded in technological innovations, see David H. Guston& Daniel Sarewitz, Real-time Technology Assessment, 23 TEC. IN SOC. (forthcoming 2001).

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their wake after changes have become entrenched or irreversible. Striking in thisregard is Professor Roger Dworkin's statement about regulation of geneticengineering more than two decades ago. Writing in the late 1970s and critiquingthe trend at the time of self-regulation by scientists of this emerging area,Dworkin stated that "our greatest need is for an institution that can anticipateproblems before options are foreclosed. 53

This urgent need remains more than two decades later. The critical functionthat the emerging biosafety regime serves, notwithstanding its limitations, is toprovide an institutional context within which problems can be anticipated andoptions considered and exercised, rather than foreclosed through inaction. Eventhough shared governance precepts, such as the precautionary principle orsocioeconomic considerations, remain contested, vague, and/or under-institutionalized, this very ambiguity and conflict suggests a pressing need tocontinue searching for shared understandings through the vehicle of globalgovernance regimes.

53. Roger Dworkin, Science, Society and the Expert Town Meeting: Some Comments on Asilomar, 51 S. CALL. REV. 1471, 1481 (1978).

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